Catalog Number

116

Brand Name

Halyard

Version/Model Number

93804

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BSY

Product Code Name

CATHETERS, SUCTION, TRACHEOBRONCHIAL

Public Device Record Key

5f071363-a2aa-4c86-ba31-9fca5bc7f537

Public Version Date

November 16, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2017

Package DI Number

30680651938047

Quantity per Package

6

Contains DI Package

20680651938040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS